The Manufacturing Associate Level I is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.
High School Diploma or Equivalent
Work Experience:
Entry Level - 0-4 years
Proven logic and decision making abilities, critical thinking skills
Strong written and verbal communication skills are required
Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate.
Attain qualification for all assigned tasks and maintain individual training plan.
Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc.
Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.
Maintain facility and equipment through routine cleaning and sanitization, support 6S programs.